歐康維視生物-B(01477.HK):OT-1001(ZERVIATE)在中國獲批III期臨牀試驗
格隆匯9月22日丨歐康維視生物-B(01477.HK)發佈公告,集團產品管線中的組胺H1受體拮抗劑OT-1001(ZERVIATE)日前獲國家藥品監督管理局藥物審評中心批准,將在中國開展III期臨牀研究,擬用作治療過敏性結膜炎患者伴隨的眼癢。
研究表明相比於現有的抗過敏治療劑,OT-1001(ZERVIATE)展現了更好的有效性及安全性。OT-1001(ZERVIATE)起效迅速,滴眼後作用持續時間長達至少8小時。OT-1001 (ZERVIATE)患者覆蓋範圍更廣,其是唯一一種除成人外還獲得美國食品藥品監督管理局批准用於治療2歲及2歲以上幼兒的眼科抗組胺藥物,可滿足目前過敏性結膜炎幼兒患者治療的臨牀需求。
OT-1001(ZERVIATE)在中國獲批III期臨牀研究標誌着集團進入臨牀後期及商業化階段的產品管線得到進一步豐富。集團將積極推進OT-1001(ZERVIATE)的III 期臨牀進展,力爭早日商業化該產品,為過敏性結膜炎臨牀治療帶來全新的解決方案。
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